Docetaxel, Cisplatin and 5-Fluorouracil in Patients with Locally Advanced Unresectable Head and Neck Cancer: A Phase I-II Feasibility Study

The document summarizes a phase I–II study conducted on 48 chemotherapy-naive patients with locally advanced unresectable squamous cell carcinoma of the head and neck (SCCHN), assessing the safety and efficacy of a chemotherapy regimen combining docetaxel, cisplatin, and 5-fluorouracil (5-FU). Patients were treated with two different dose levels, with dose level I being recommended for further studies due to dose level II's higher toxicity rates. The study reported a 71% response rate with no complete responses, a median survival of 18.7 months, and survival rates at 12, 18, 24, and 36 months of 68.8%, 53.8%, 40.9%, and 31.1%, respectively. The study concluded that the treatment was feasible and active, suggesting that it should be compared to the standard PF regimen in future phase III trials.